BIIB014 Cardiovascular Monitoring Study

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIIB014 100mg; Drug: BIIB014 50mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01035515

204HV102

Details and patient eligibility

About

The study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects
• Between the ages of 18 and 50, inclusive.
• Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion criteria

• Clinically significant abnormalities (as determined by the Investigator)
• Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)

Trial design

24 participants in 6 patient groups

Arm One

Experimental group

Description:

Arm 1 of 6 cross-over arms

Treatment:

Drug: BIIB014 100mg

Drug: BIIB014 50mg

Drug: Placebo

Arm Two

Experimental group

Description:

Arm 2 of 6 cross-over arms

Treatment:

Drug: BIIB014 100mg

Drug: BIIB014 50mg

Drug: Placebo

Arm Three

Experimental group

Description:

Arm 3 of 6 cross-over arms

Treatment:

Drug: BIIB014 100mg

Drug: BIIB014 50mg

Drug: Placebo

Arm Four

Experimental group

Description:

Arm 4 of 6 cross-over arms

Treatment:

Drug: BIIB014 100mg

Drug: BIIB014 50mg

Drug: Placebo

Arm Five

Experimental group

Description:

Arm 5 of 6 cross-over arms

Treatment:

Drug: BIIB014 100mg

Drug: BIIB014 50mg

Drug: Placebo

Arm Six

Experimental group

Description:

Arm 1 of 6 cross-over arms

Treatment:

Drug: BIIB014 100mg

Drug: BIIB014 50mg

Drug: Placebo